Tariffs have been a defining feature of US trade policy under President Donald Trump’s second administration. Since Trump unveiled his “reciprocal” tariff policy in April 2025, the landscape has shifted repeatedly.In February 2026, the US Supreme Court invalidated tariffs imposed…
BUSINESS
FDA Delays Review of Leqembi Iqlik for Alzheimer’s Initiation Therapy
The US FDA has extended by three months its review of the subcutaneous autoinjector formulation of Eisai’s anti-amyloid antibody Leqembi (lecanemab), as a once-weekly initiation therapy for early Alzheimer’s disease. The new target action date has been set for August…
To read the full story
Related Article
- Leqembi Iqlik Now Available for Alzheimer’s Initiation Use in US
August 25, 2026
- FDA Greenlights Leqembi Iqlik for Alzheimer’s Initiation Therapy
July 14, 2026
- Leqembi Iqlik Now under FDA Review for Initiation Phase
January 26, 2026
- Rolling Submission for Leqembi SC Starting Dose Completed in US
November 27, 2025
- Leqembi Iqlik Autoinjector Now Available in US: Eisai/Biogen
October 8, 2025
- Eisai Begins FDA Rolling Submission for Leqembi SC for Starting Dose
September 4, 2025
- FDA Clears Leqembi Autoinjector; Launch Set for Oct. 6
September 2, 2025
- FDA Accepts Leqembi SC for Review; Target Date Set to Aug. 31
January 15, 2025
- FDA Rolling Submission for Leqembi SC Completed: Eisai
November 5, 2024
- Eisai Begins Rolling Submission for Subcutaneous Leqembi in US
May 16, 2024
BUSINESS
- Regeneron Files MM Drug Linvoseltamab in Japan
November 6, 2026
- Fuji Pharma Recalls Eylea Biosimilar Lots over Faulty Finger Grips
November 6, 2026
- Medipal Sets Dec. 15 Shareholder Meeting, Opposes Chairman’s Ouster
November 6, 2026
- Nitrosamine Impurities Reported for Generic Telmisartan; No Recalls Planned
November 6, 2026
- Bracco Japan to Acquire Iopamiron from Bayer in July 2027
November 6, 2026
As Japan’s budget season draws near, the Ministry of Finance (MOF) has renewed its push for a full-scale “off-year” drug…
Japan is pressing ahead with broader drug price cuts under its cost-effectiveness assessment (CEA) system, despite lingering questions over the…
Members of a key reimbursement policy panel on October 28 raised no objections to expanding drug makers’ access to deliberations…
Eli Lilly’s breast cancer drug Imulrio (imlunestrant) is finally joining Japan’s NHI price list on October 14, nearly 300 days…
Japan’s Ministry of Health, Labor and Welfare (MHLW) on March 5 unveiled the revised NHI prices for drugs subject to…
Japan’s Central Social Insurance Medical Council (Chuikyo) on November 5 approved the reimbursement listing for a slate of new medicines,…
The Japanese government approved a bill to amend the Pharmaceuticals and Medical Devices (PMD) Act at its Cabinet meeting on…
Japan’s health ministry doled out regulatory approvals for a throng of new medicines on December 27 including Eli Lilly’s obesity…
Japan’s all-important reimbursement policy panel on December 20 approved an outline of drug pricing reforms for FY2024, which enshrines a…